Kornimate/medical-research-clean huggingface dataset:
efficacy study to evaluate the effect of nitric oxide on the treatment of tinea pedis (athlete's foot)

Conditions: Tinea

Summary: the purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with tinea pedis


Eligibility criteria:
inclusion criteria: * positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination * must have a clinical symptom severity score of at least 20 on a possible 64 point scale * written informed consent must be obtained from the subject. * must ≥ 19 years of age * must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial. * must agree to take measures to avoid pregnancy during the 12 day (or 26 day if in cross over group) study period exclusion criteria: * has a diagnosis of either psoriasis or eczema * has a visual diagnosis, by the investigator, of onychomycosis. * use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (oxistat®, glaxo smith kline), sulconazole, naftifine (naftin®, merz), terconazole, econazole nitrate (spectazole®, ortho-mcneil), butoconazole ,fluconazole, ciclopirox olamine-(loprox®, medicis), tolnaftate, haloprogin), zeasorb-af , antibacterials and corticosteroids in the preceding 5 days of screening visit (day 1) * use of systemic corticosteroids in the preceding 7 days of screening visit (day 1) * use of systemic antifungals in the preceding 7 days of screening visit (day1) including - (terbinafine - (lamisil®, novartis), itraconazole - (sporanox®, janssen), fluconazole- (diflucan®, pfizer), ketoconazole, miconazole, griseofulvin (gris-peg®, pedinol), butoconazole, terconazole, potassium iodide) * has used any investigational drug(s) within 30 days preceding screening visit (day 1) * has cardiovascular disease, diabetes mellitus, cushing's disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy * is pregnant or is a nursing mother * is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) * is \< 19 years of age * suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety
neuroendocrine mechanisms in behavioral treatment of insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

there is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. the aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. we anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. we also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. if achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.

Eligibility criteria:
inclusion criteria: * primary insomnia for 6 months * average total wake time \>60 minutes and sleep efficiency \<80% * at least 1 daytime complaint due to insomnia * adequate opportunity and circumstance for sleep exclusion criteria: * current psychiatric condition * medical condition that interferes with sleep * pregnancy * rotating shift work, night work or transcontinental travel during study * anticipated major life stressor over the course of the study * use of hypnotic or psychoactive medications * no idiopathic or sleep state misperception insomnia

Keywords: sleep arousal stress cortisol catecholamines
microsurfaced grafts in deep burn wounds

Conditions: Burns; Wound Heal

Summary: this study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of microsurfaced vs control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. this study will be performed in 2 parts: time to wound bed preparedness through 6 weeks (part a) and wound site healing, graft take and long-term scar outcomes (part b). subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.


Eligibility criteria:
inclusion criteria: * signed informed consent by patient or legally authorized representative (lar) * subject with deep partial or full thickness burn injury due to flame burn, scald injury or contact burn * study burn site large enough to accommodate placement of control and microsurfaced cadaveric graft (minimum 4 cm2 each) at the same location or 2 study burn sites large enough to each accommodate control and microsurfaced cadaveric graft, respectively at minimum 4 cm2. * total body surface area burned (tbsa) total ≤30 % * admission within 72 hours of burn injury * non-infected wound as diagnosed by the attending physician upon admission * treated as an outpatient or in an observational setting * 21 years of age or older exclusion criteria: * burns involving the face * causes other than contact burn, flame or scald injuries (i.e., electrical, chemical or frostbite) * admission time greater than 72 hours after the injury * wounds noted to be infected at admission * is pregnant or plans to become pregnant * is nursing or actively lactating * developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years. * active alcohol or substance abuse in the opinion of the investigator that could impair the subject's participation in the study protocol or record study materials * any medical condition or co-morbidity that in the opinion of the investigator, would prevent successful participation in the study
efficacy of mhealth applications in weight management in a population affected by overweight or obesity

Conditions: Overweight and Obesity

Summary: the purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes in patients with overweight and obesity. this study will involve a 6-month long commitment where participants will be expected to use an mhealth app daily, weigh themselves and check their fasting blood glucose levels every morning.


Eligibility criteria:
inclusion criteria: * between the age of 18-64 * bmi ≥ 25 * owns or has access to a bathroom weight scale * owns a smartphone and willing to download mobile app exclusion criteria: * on medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications. * medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay

Keywords: adiposity
hydroxychloroquine in covid-19 patients

Conditions: COVID-19

Summary: many reports argued about the possible beneficial effects of hydroxychloroquine in treating covid-19 patients and this study was designed to investigate this claim


Eligibility criteria:
inclusion criteria: confirmed cases of sars-cov-2 by pcr exclusion criteria: less than 18 years old known hypersensitivity to the drug
the effect of erythropoietin in the treatment of scleral necrosis

Conditions: Conjunctival and Scleral Avascular Lesions

Summary: patients with acute avascular lesions of the conjunctiva and sclera will be included in the study. patients will undergo a complete eye examination including a slit lamp, intraocular pressure measurement, and fundoscopy with dilated pupil. at the same time, laboratory examination including measurement of fasting blood sugar (fbs) level, complete blood count (cbc) and systemic blood pressure will be performed. patients will be randomly divided into three groups. the groups will receive sham drops (normal saline), erythropoietin 3000 units in normal saline, and erythropoietin 6000 units in normal saline every 6 hours respectively. meanwhile, all patients will receive the usual treatments based on the cause of scleral necrosis. eye examinations will be done daily in the first week, every other day in the second week, and then twice a week until the complete recovery of avascular lesions. in each examination, with fluorescein staining, the size of the conjunctival epithelial defect will be determined. also, the dimensions of the avascular area of the sclera will be determined. other examinations include measurement of visual acuity and intraocular pressure, and the patient will be evaluated in terms of iris and retinal neovascularization. the photoslit lamp will be done before starting the study and then every week. complete healing of the lesion is defined by complete vascularization and epithelization of the ischemia site. after the complete recovery of conjunctival and scleral necrosis, the erythropoietin drop will be stopped and the examinations including blood pressure measurement, cbc, diff and fbs will be repeated.


Eligibility criteria:
inclusion criteria: * patients with acute conjunctival and scleral avascular lesions resulting from ocular surgery (such as pterygium resection, glaucoma, strabismus, vitreous and retinal surgery), chemical and thermal burns, and collagen-vascular disease. exclusion criteria: * a history of ocular surface tumors * a history of tumors in any part of the body * iris and retinal neovascularization for any reason * proliferative diabetic retinopathy * and systemic hypertension * if the sclera is severely thinned and the risk of perforation of the globe is imminent, the patient is excluded from the study.
pharmacokinetics and safety of fevipiprant in patients with renal impairment compared to matched healthy subjects

Conditions: Renal Insufficiency

Summary: the aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (pk) to the extent that dosage adjustment is appropriate for this patient population. the study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.

the purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information

Eligibility criteria:
inclusion criteria: * healthy subjects must satisfy the criteria for normal renal function as evidenced by normal glomerular filtration rate (gfr): egfr ≥ 90 ml/min/1.73m2; each healthy subject must match in age (+/- 10years), gender, smoking status, and weight (+/- 15%), a patient from the renail impaired patient groups: * a body mass index (bmi) within the range of 18 - 36 kg/m2 * esrd patients on hemodialysis: an glomerulo filtration rat gfr of \< 15 ml/min/1.73 m2 * patients with severe renal impairment: gfr of\< 30 ml/min/1.73m2 (without need of hemodialysis); * patients with moderate renal impairment: 30 ml/min/1.73m2 ≤ egfr \< 60 ml/min/1.73m2; * patients with mild impairment: 60 ml/min/1.73m2 ≤ egfr \< 90 ml/min/1.73m2 exclusion criteria: * pregnant or nursing (lactating) women * history or evidence of any inherited bilirubin disease or disorder * subjects participating in another study * malignancies in the past * hemoglobin levels below 10 g/dl at screening * hiv positiv * heavy smokers (≥20 cigarettes per day) * liver disease, as indicated by alt, γ-gt, ast and alkaline phosphatase which should not exceed twice the upper limit of normal and should be stable (e.g. increased liver values known from previous patient records). serum bilirubin \> 27 μmol/l (1.6 mg/dl) * clinically significant ecg changes and/or arrhythmias * chronic infection with hepatitis b (hbv) or hepatitis c (hcv)

Keywords: end stage renal disase esrd dialysis effect on pharmacokinetics pk renal impairment
investigation of neurocognitive measures of sport-related injury

Conditions: Concussion, Brain

Summary: the overall objective is to provide an onsite diagnosis with subsequent return to play criteria, as well as, lower the risk of traumatic brain injury by primary prevention through cervical spine neuromuscular control and vision training. the central hypothesis is that improved understanding of neurocognitive measures and function will provide improved diagnosis of concussion and help reduce the incidence of subsequent sports-related injury.


Eligibility criteria:
inclusion criteria: * 12-30 year old competitive or recreational athletes exclusion criteria: * pre-existing condition preventing the ability to perform neck range of motion or a neck strength assessment * recent exposure to head lice * known or suspected pregnancy

Keywords: brain concussion neck strength sport prevention
arimidex therapy compliance electronic monitoring system

Conditions: Breast Cancer

Summary: artemis is a study to assess how educational material affects overall adherence to anastrozole by evaluation of patients' electronically compiled dosing histories. patients' dosing times are compiled electronically using medication event monitoring system" (mems®) in order to be able to gather accurate, objective and up-to-date patients' dosing histories. for subjects in group a, the control group, the adherence to anastrozole in the standard clinical practice will be evaluated. for subjects in group b, on top of the standard clinical practice, they will also receive educational material by mail at week 0 (study registration), week 2, week 4, week 6, week 8, week 12, month 5, month 7, and at month 10. this procedure is the same as in the ongoing cariatide study. one of the reasons of poor adherence (either early discontinuation of the treatment or missing doses while still engaged to the therapy) can be some side effects experienced by the patients during the anastrozole treatment. recording the reasons at discontinuation allows us to identify reasons for treatment discontinuation. recording reasons of anastrozole interruptions during the study period allows us to relate these events to patients' adherence to anastrozole. during the study, no pro-active safety data collection will take place. spontaneous reported adverse drug reactions (adrs) will be reported according to local post-marketing pharmacovigilance regulations.


Eligibility criteria:
inclusion criteria: * postmenopausal women with hormone sensitive early breast cancer. * documented decision of treatment with anastrozole which will start in 13 weeks according to current smpc or current treatment with anastrozole according to current smpc, that has not exceeded thirteen weeks before enrollment. * subjects who accept to use mems® monitors to automatically compile their drug dosing histories. exclusion criteria: * concomitant or previous use of adjuvant tamoxifen, letrozole or exemestane for the current tumour. * involvement in the planning and/or conduct of the study (applies to both astrazeneca staff or staff at the study site). * participation in another clinical study with an investigational product during the last 3 months.

Keywords: compliance early breast cancer
reducing hypoglycemia fear in parents of young children with type 1 diabetes

Conditions: Parents

Summary: pilot of a novel video-based telemedicine intervention to reduce fear of hypoglycemia in parents of young children with type 1 diabetes.

this was a two group randomized controlled study using a wait-list control design. all participating parents had the opportunity to receive 10 video-based telemedicine sessions administered over 13 weeks. study assessments took place at baseline, post-treatment, and 3 month followup. study outcomes included parent reported hypoglycemia fear, parenting stress, diabetes distress, and child glycated hemoglobin.

Eligibility criteria:
inclusion criteria: * parents of children, between 1-6 years old, with type 1 diabetes for at least 6 months, on either multiple daily injections or an insulin pump, and parents speak english exclusion criteria: * families of children who are older than 6 years-old and or do not have type 1 diabetes; children follow a conventional insulin regimen
a trial to evaluate faropenem medoxomil in the treatment of acute otitis media

Conditions: Otitis Media

Summary: the study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in costa rica and israel. the primary objective of this trial will be to describe bacteriologic efficacy in those with initial culture positive specimens with different dosages of faropenem

the study will be conducted in infants and children with acute otitis media, 6 months to \<7 years old, in costa rica and israel. faropenem is to be used as therapy for both simple and complicated aom.

Eligibility criteria:
inclusion criteria: * acute otis media exclusion criteria: * any antibiotic for more than 24 hours (unless a treatment failure) within 7 days prior to enrollment

Keywords: aom
volumetric impedance to guide stroke response

Conditions: Stroke, Acute

Summary: assess the ability of the visor system to detect hemispheric bioimpedance asymmetry


Eligibility criteria:
inclusion criteria: * being evaluated as a suspected stroke exclusion criteria: -
predictors of outcome in t-pa treated stroke.

Conditions: Ischemic Stroke

Summary: stroke is among the most disabilitating diseases worldwide in terms of numbers affected and its consequences. a relatively new and well documented treatment of acute ischemic stroke today is tpa (tissue plasminogen activator; will be called thrombolysis from now on) unfortunately only a minority of patients is given this treatment. the large randomised controlled trials that investigated the safety and efficacy of thrombolytic therapy in treatment of acute stroke did not include patients over 80 years. in an aging population in the western world it will be of importance to investigate whether this treatment is safe and effective in this group. both sorlandet hospital kristiansand norway and bergen hospital have administered thrombolysis to selected patients over 80 years the last years. in addition there has been a registration of patients in stroke registers at both locations. this lays a foundation for further investigation. in association with bergen the investigators have included 77 patients over 80 years treated with thrombolysis. in addition the investigators have 85 patients treated with tpa below 80 years. in our cohort the investigators are going to compare outcome in the 2 groups. in addition the investigators are going to perform a regression analysis of selected variables to see if there is an association of those variables with predefined outcome measures. our outcome measures is as follows: mrs=6 (death)and mrs 0-1(good outcome) on 3 months control. the third outcome measure will be developement of sich secondary to tpa treatment. as definition of sich we have chosen the same definition as ecass.


Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke treated with thrombolysis over 80 years between 01.01.2007-28.02.2010 from predefined centers. * patients with acute ischemic stroke treated with thrombolysis at sorlandet hospital kristiansand below 80 years in the same defined period. two patients were excluded due to missing data at three months control
two-year follow-up of a mindfulness-based intervention in children.

Conditions: Mental Health Issue

Summary: the primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called training for mindfulness and resilience (tmr), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up. methods the participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. participants were randomised into either tmr intervention group (n=22) or control group, receiving best current practice (n=12). the investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either tmr or control, as well as at 6 months, 1 year and 2 years after treatment period.


Eligibility criteria:
inclusion criteria: * f32.0 mild depressive episode * f32.1 moderate depressive episode * f41 anxiety disorders * f43 reactions to stress * f51 nonorganic sleep disorders * f93 emotional disorders with onset specific to childhood * f94.8 other childhood disorders of social functioning * f94.9 other childhood disorder of social functioning, unspecified exclusion criteria: * ongoing treatment for severe psychiatric disorders (f20-29, f31-f33.3) * cognitive disorders * difficulties in understanding swedish * neuropsychiatric considerations and diagnosis * learning disabilities with difficulties in verbal understanding * ongoing parental conflict in conjunction with separation/divorce. * attending less than 5 of the 8 sessions of the tmr program.